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量身定制干预措施以提高帕金森病老年患者的药物依从性:一项随机对照试验(AdhCare)的研究方案

Tailored interventions to improve adherence to medication in elderly patients with Parkinson's disease: a study protocol for a randomized controlled trial (AdhCare).

作者信息

Mendorf Sarah, Teschner Ulrike, Lehmann Thomas, Prell Tino, Mühlhammer Hannah Maria

机构信息

Department of Neurology, Jena University Hospital, Jena, Germany.

Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Germany.

出版信息

Trials. 2023 Oct 12;24(1):668. doi: 10.1186/s13063-023-07663-9.

Abstract

BACKGROUND

Nonadherence to medication is a major issue in patients with chronic disorders such as Parkinson's disease (PD). Many interventions for increasing adherence have been tested, and these have shown weak-to-moderate efficiency. Although the best methods to improve adherence remain unclear, it is reasonable to use tailored interventions instead of the "one-size-fits-all" approach.

METHODS

A randomized, controlled, triple-blinded trial in elderly patients with PD is conducted to test the efficacy of AdhCare, a tailored intervention to enhance adherence compared with that achieved with routine care (64 participants per arm). Motor function, quality of life, and adherence measures will be assessed at baseline and at 3 and 6 months of follow-up. The type of intervention depends on the main personal reason for nonadherence (e.g., forgetting to take the medication or poor knowledge about the medication).

DISCUSSION

The results of this study will provide valuable information for health professionals and policymakers on the effectiveness of tailored interventions in elderly patients with PD.

TRIAL REGISTRATION

German Clinical Trials Register DRKS00023655. Registered on 24 February 2021. Last update on 22 March 2023.

摘要

背景

不遵医嘱服药是帕金森病(PD)等慢性疾病患者的一个主要问题。许多提高依从性的干预措施已经过测试,但其效果从微弱到中等不等。尽管改善依从性的最佳方法仍不明确,但采用量身定制的干预措施而非“一刀切”的方法是合理的。

方法

在老年帕金森病患者中进行一项随机、对照、三盲试验,以测试AdhCare的疗效,AdhCare是一种与常规护理相比用于提高依从性的量身定制干预措施(每组64名参与者)。将在基线以及随访3个月和6个月时评估运动功能、生活质量和依从性指标。干预类型取决于不遵医嘱的主要个人原因(例如,忘记服药或对药物了解不足)。

讨论

本研究结果将为卫生专业人员和政策制定者提供有关量身定制干预措施对老年帕金森病患者有效性的宝贵信息。

试验注册

德国临床试验注册中心DRKS00023655。于2021年2月24日注册。最后更新于2023年3月22日。

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